Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NoV GI.1/GII.4 Bivalent VLP Vaccine · 3 trials · 4 indications
Acute gastroenteritis (AGE) is a sudden inflammation or swelling in the lining of the stomach causing diarrhea and vomiting. A norovirus AGE case was defined as meeting the work-up definition plus a norovirus positive stool sample or vomitus sample confirmed by reverse transcriptase polymerase chain reaction (RT-PCR). The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains excluding co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4.
Serum samples were obtained for assay validation of the pan-Ig enzyme-linked immuno-sorbent assay (ELISA) and the histoblood group antigen (HBGA) binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 8 are reported.
Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 15 are reported.
Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 29 are reported.
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (\>) 24 hours \[24h\] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter \[cm\] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity).
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfered with activity); Moderate (repeated use of non-narcotic pain reliever \>24h or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 cm and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity).
Elevated oral temperature:Mild(38-38.4 Celsius\[C\]);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever\>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/\<400gram\[g\]/24h);Moderate(4-5stools/400-800g/24h);Severe(\>=6watery stools/\>800g/24h/required intravenous\[IV\]hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/\>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Elevated oral temperature:Mild(38-38.4 C);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever\>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/\<400g/24h);Moderate(4-5stools/400-800g/24h);Severe(\>=6watery stools/\>800g/24h/required IV hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/\>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry or hematology) collected throughout study.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | NoV placebo-matching 0.5 mL solution for injection, intramuscularly (IM), once, on Day 1. |
| NoV GI.1/GII.4 Bivalent VLP Vaccine | EXPERIMENTAL | NoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine, 0.5 mL injection, intramuscularly (IM), once, on Day 1. |
| NoV Vaccine | EXPERIMENTAL | Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1. |
| Saline | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NoV Placebo-matching Saline | BIOLOGICAL | NoV placebo-matching saline (0.9% sodium chloride). |
| NoV GI.1/GII.4 Bivalent VLP Vaccine | BIOLOGICAL | NoV bivalent VLP vaccine, adjuvanted with 500 µg aluminum as Al(OH)3. |
| Saline | BIOLOGICAL | Two doses 28 days apart |
Inclusion Criteria: 1. Participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures after the nature of the trial has been explained according to local regulatory requirements. 2. Male or female participants, 18 ...
NoV GI.1/GII.4 Bivalent VLP Vaccine is an investigational vaccine being studied for the prevention of gastroenteritis caused by norovirus. It is designed for use in healthy volunteers and adults. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
NoV GI.1/GII.4 Bivalent VLP Vaccine targets norovirus genotypes GI.1 and GII.4. It is a bivalent virus-like particle vaccine designed to elicit an immune response against these two norovirus strains, which are common causes of acute gastroenteritis.
NoV GI.1/GII.4 Bivalent VLP Vaccine is being developed by Takeda Pharmaceutical Company Limited, which is listed on the stock exchange under the ticker TAK. The company has conducted clinical trials to evaluate the vaccine's safety and immunogenicity.
NoV GI.1/GII.4 Bivalent VLP Vaccine has completed Phase 1 and Phase 2 clinical trials. The most advanced completed trial was a Phase 2 efficacy study. The vaccine remains investigational and has not received FDA approval.
NoV GI.1/GII.4 Bivalent VLP Vaccine has been studied in three completed clinical trials: NCT01168401, a Phase 1 study in 102 participants; NCT02475278, a Phase 2 study in 50 participants; and NCT02669121, a Phase 2 efficacy study in 4748 healthy adults. All trials were conducted in the United States.
NoV GI.1/GII.4 Bivalent VLP Vaccine is a norovirus vaccine candidate. It is designed to protect against norovirus infection, which causes gastroenteritis. The vaccine targets the GI.1 and GII.4 norovirus genotypes and is being developed by Takeda.